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January 31, 2012 - Annual figures Veterinary Medicinal Products Unit MEB 2011
The Veterinary Medicinal Products Unit (VMPU) of the Medicines
Evaluation Board (MEB) approved 159 new veterinary medicinal
products and entered them in the register in 2011. As of 31
December 2011, the number of authorised veterinary medicinal
products was 2,310. This is slight increase versus 31 December 2010
(2,246 authorised veterinary medicinal products).
Active role in Europe
A veterinary medicinal product can receive a national marketing
authorisation through a national procedure, a decentralised
procedure (DCP) or a mutual recognition procedure (MRP). Veterinary
medicinal products may receive European marketing authorisation
from the European Committee using a Centralised Procedure. The
MEB/VMPU has a role in all procedures as the national medicinal
products authorisation agency.
The MEB/VMPU acted as a reporter for one centralised procedure
in 2011 for a new veterinary medicinal product, as a reporter for a
change application for a Maximum Residue Limits (MRL*) on one
occasion, as a reporter for an expansion application for an MRL on
one occasion, as a co-reporter for an application for expansion of
an MRL on one occasion and as a coordinator for a request for
scientific advice on one occasion.
In 2011 the MEB/VMPU performed the role of Reference Member
State (RMS) in 16 of the overall total of 171 European application
procedures for authorisation of a veterinary medicinal product
(approx. 10 %). This places the Netherlands in fifth place on the
list of most active countries. Besides the marketing
authorisation activities for veterinary medicinal products, the
Veterinary Medicinal Products Unit issued 1,462 export certificates
and 1011 (European) batch approvals of veterinary vaccines. The
number of batch approvals is much the same as in 2010; for export
certificates it signifies a decrease of 30% versus 2010.
This Annual Notice is based on currently available data. The
final data will be established later and will be stated in the
annual report for 2011.
The MEB evaluates and monitors the efficacy, risks and quality
of human and veterinary medicinal products. The MEB also evaluates
the safety of novel foods for human consumption.
* Maximum Residue Limits: An MRL dossier must be approved for
every active compound that is administered to food-producing
animals. The waiting times (the time that must be observed between
administration and the time at which the milk, eggs or meat becomes
fit for human consumption again) are determined using the set
MRLs.
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